For those subjects who achieve an objective response, to assess the time to tumor response and duration of response;

To assess the time to subsequent therapy in each arm;

To assess the Health-related Quality of Life (HRQOL) outcomes (EORTC QLQ-C30 and QLQ-MY20) and the Brief Pain Inventory- Short Form (BPI-SF);

To measure the serum concentrations of elotuzumab in the presence of lenalidomide and dexamethasone;

To evaluate the immunogenicity of elotuzumab.

To explore the relationship between the effectiveness of elotuzumab and high risk cytogenetic factors and sMICA (soluble major histocompatibility complex classI-related chain A) levels.

Inclusion Criteria

Inclusion Criteria

Signed Written Informed Consent

Subject is, in the investigator�s opinion, willing and able to comply with the protocol requirements.

Subject has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.

Target Population

Age ≥ 18 years or legal age of consent per local regulations.

ECOG performance status ≤ 2.

Life-expectancy > 3 months.

Newly diagnosed, untreated, symptomatic, documented myeloma AND;

Who are not candidates for high-dose therapy plus SCT because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old, AND;

Measureable disease (patient must meet one of these criteria)

serum IgG M-protein ≥ 0.5 g/dL OR

serum IgA M-protein ≥ 0.5 g/dL OR

serum IgM M-protein ≥ 0.5 g/dL OR

serum IgD M-protein ≥ 0.05 g/dL OR

Urine M-protein ≥ 200 mg/24-hour

Age and Reproductive Status

Women of childbearing potential (WOCBP) and men must be using 2 acceptable methods of contraception to avoid pregnancy throughout the study for a period of at least 1 month (4 weeks) before and women for up to 8 weeks, men for up to 90 days after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. See Section 3.3.3 for the definition of WOCBP and also refer to the Revlimid risk management plan guidelines.

WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG). The first should be performed within 10 - 14 days and the second within 24 hours prior to the start of the investigational product. A prescription for lenalidomide for a female of childbearing potential must not be issued by the prescriber until negative pregnancy tests have been verified by the prescriber.

Women must not be breastfeeding.

Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile; see Section 3.3.3 for the definition of WOCBP) and men.

Sexually active fertile men must use effective birth control if their partners are WOCBP. Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP, even if they have had a successful vasectomy, and must agree to not donate semen during study drug therapy and for 90 days after therapy.

Subjects must be willing to refrain from blood donations during study drug therapy and for 8 weeks after therapy.

Exclusion Criteria

Exclusion Criteria

Target Disease Exceptions

Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma.

Platelets < 75,000 cell/mm3 (75 x 109/L). Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory value.

Hemoglobin < 8 g/dL. Qualifying laboratory value must occur at most recent measurement prior to randomization and must be no more than 14 days prior to randomization. No transfusions are allowed within 72 hours prior to qualifying laboratory value.

short course (of ≤ 4 days) of 40 mg dexamethasone or equivalent for emergency use (baseline M proteins must be drawn after this short course and prior to randomization);

≤ 10 mg prednisone or equivalent per day;

Steroid with little to no systemic absorption (ie, topical or inhaled steroids).

Major surgery within 4 weeks prior to randomization (kyphoplasty is not considered major surgery); subjects should have been fully recovered from any surgical related toxicities.

Allergies and Adverse Drug Reaction

Known hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation or recombinant protein.

Sex and Reproductive Status

Sexually active fertile men not using 2 forms of effective birth control if their partners are WOCBP.

Other Exclusion Criteria

Prisoners or subjects who are involuntarily incarcerated.

Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.

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Clinical Trials

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